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Completed

NCT Number: NCT01713283

Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

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Key information

Conditions

Hepatitis C Virus Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
  • Treatment-experienced or treatment-naive
  • Chronic genotype 4 HCV infection
  • Not co-infected with HIV
  • Screening laboratory values within defined thresholds
  • Use of highly effective contraception methods
  • Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion criteria

  • History of any other clinically significant chronic liver disease
  • Pregnant or nursing female or male with pregnant female partner
  • History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse

Treatment and study plan

SOF

Drug

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

Other names: GS-7977, PSI-7977, Sovaldi®

RBV

Drug

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)

    Time frame: Posttreatment Week 12

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

  2. Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

    Time frame: Up to 24 weeks

    The percentage of participants discontinuing any study drug due to an adverse event was summarized.

Secondary outcomes

  1. Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    Time frame: Posttreatment Weeks 4 and 24

    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

  2. Percentage of Participants Experiencing On-treatment Virologic Failure

    Time frame: Up to 24 weeks

    On-treatment virologic failure was defined as:

    • Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
    • Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
    • Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment

  3. Percentage of Participants Experiencing Viral Relapse

    Time frame: Up to Posttreatment Week 24

    Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 24, 2012
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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